BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3895434 · Received June 25, 2014

    Report

    Report Number
    2029214-2014-00354
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THE PIPELINE WAS IMPLANTED IN THE PATIENT AND THE PUSHWIRE WAS DISCARDED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A SMALL ANEURYSM WITH A WIDE NECK LOCATED IN THE PICA LOCATED IN THE (POSTERIOR INFERIOR CEREBELLAR ARTERY). ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE COULD NOT BE RELEASED FROM THE CAPTURE COIL DESPITE ROTATING THE PUSHWIRE AND ADVANCING IT WHEN THERE WAS 4MM OF THE PIPELINE LEFT IN THE MICROCATHETER. IN THE PROCESS OF ROTATING THE PUSHWIRE, THE REMAINING PIPELINE WAS PULLED OUT THE MICROCATHETER AND IT ADVANCED THE PIPELINE MORE DISTAL THAN DESIRED. THE CAPTURE COIL WAS EVENTUALLY BUMPED OFF THE PIPELINE BY ADVANCING THE CATHETER THROUGH THE OPEN PROXIMAL PART OF THE PIPELINE UP TO THE DISTAL PART OF THE PIPELINE AND NUDGING IT OPEN FROM THE INSIDE. A SECOND PIPELINE WAS ALSO PLACED DUE TO LESS THAN IDEAL COVERAGE OF THE ANEURYSM NECK. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370018 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77425-12 9911771

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention| S